Study on Pharmacokinetics and Clinical Efficacy of Dexmedetomidine Hydrochloride Microneedles(DEX) for Preoperative Sedation in Children
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Adverse Event and Serious Adverse Event
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety and the population pharmacokinetic characteristics of Dexmedetomidine Hydrochloride Microneedles for preoperative sedation in children
详细描述
A multicenter, randomized, double-blind, placebo-controlled Phase IIa clinical trial, using Dexmedetomidine Hydrochloride Microneedles as an investigational drug and the Dexmedetomidine Hydrochloride Microneedles blank preparation as a comparator. After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two arms. The subjects should follow designated physician's instructions accurately during the clinical trial period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 2 years to 6 years (inclusive ), any genders;
- •Body weight meeting the criteria:
- •Scheduled to undergo general anesthesia for surgery/procedure
- •American Society of Anesthesiologists（ASA） I~II
- •Provide written informed consent from the legal guardian
排除标准
- •Allergy to any component of the Dexmedetomidine Hydrochloride Microneedle Patch, history of allergy to other sedative drugs, or known allergy to α2-adrenergic receptor-related products or excipients;
- •Having received other sedative-hypnotic or analgesic drugs prior to randomization, where the time since last dose is less than 7 half-lives;
- •History of bronchial asthma, chronic respiratory diseases, or other severe respiratory system diseases;
- •History of neurological diseases such as ischemic encephalopathy encephalopathy, craniocerebral injury, etc., which in the investigator's judgment may affect the evaluation of the investigational product;
- •History of thoracic, cardiac, or brain surgery;
- •Presence of large areas of skin damage or skin conditions unsuitable for topical patch application on the inner aspects of both forearms or the outer aspects of both thighs;
- •Abnormal liver/kidney function test values (ALT or AST >1.5 times the upper limit of normal [ULN], or bilirubin >1.5 × ULN, or serum creatinine >1.5 × ULN);
- •Severe cardiovascular diseases (e.g., fulminant myocarditis, high-grade or third-degree atrioventricular block, sick sinus syndrome, severe arrhythmia, cardiomyopathy, severe pulmonary hypertension, pulmonary atresia, heart failure);
- •Anemia requiring treatment, as judged by the investigator (hemoglobin <80 g/L);
- •Use of highly selective α2 agonists or antagonists prior to randomization, where the time since last dose is less than 7 half-lives;
- •Participation in another clinical trial (meaning having received an investigational drug or device) within 3 months prior to screening;
- •Presence of severe psychiatric illness at screening leading to inability or unwillingness to cooperate;
- •Other situations deemed by the investigator as unsuitable for inclusion.
研究组 & 干预措施
Part 1
16 Participants will receive the Dexmedetomidine hydrochloride Microneedles identified in Part 1 of the study. Randomized in a 1:1 ratio through the randomization system, and assigned to medium-pressure group or low-pressure group. A total of 16 children with a high body weight (weight ≥ 19.4 kg) will be included. They will be randomly divided into a medium-pressure group and a low-pressure at a ratio of 1:1.
干预措施: Dexmedetomidine hydrochloride Microneedles (Drug)
part2
Participants will receive the dose identified in Part 1 of the study. A total of 24 children with high body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.
干预措施: Dexmedetomidine hydrochloride Microneedles (Drug)
part2
Participants will receive the dose identified in Part 1 of the study. A total of 24 children with high body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.
干预措施: Placebo (Drug)
part3
Participants will receive the dose identified in Part 2 of the study. A total of 24 children with low body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.
干预措施: Dexmedetomidine hydrochloride Microneedles (Drug)
part3
Participants will receive the dose identified in Part 2 of the study. A total of 24 children with low body weight (weighing less than 19.4 kg) will be included. They will be randomly divided into the low dose group , the high dose group and placebo group at a ratio of 1:1:1. They will be given Dexmedetomidine hydrochloride Microneedles or placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse Event and Serious Adverse Event
时间窗: Day2
Incidence rate of Adverse Event and Serious Adverse Event
次要结局
- Maximum blood concentration(0 to 4 hour after administration)
- Ramsay scale(0 minute to 45 minutes after administration)
- Sedation Success Rate(0 minute to 45 minutes after administration)